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Clinical Trial Summary

To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRT


Clinical Trial Description

<Treatment phase> Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. External beam radiotherapy begins 2-7 days after the first dose of nivolumab. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent or study closure. <Follow-Up phase > After the treatment phase, subjects will undergo follow up for survival every 12 weeks (± 7 days) from the last dose or the use of other anticancer treatments and/or therapies, and the survival follow up will be performed for at least 18 months after the enrollment of the last subject. The patient will be followed for survival follow up and the use of other anticancer treatments and/or therapies. Based on the assumed dropout rate of 12%, a total of 50 subjects need to perform the study (50=44/(1-0.12)) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04611165
Study type Interventional
Source National Cancer Center, Korea
Contact
Status Enrolling by invitation
Phase Phase 2
Start date November 15, 2019
Completion date December 30, 2022

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